Progressive ScoliosisNEMOSTNCT02266667
Surgical Treatment of Progressive Scoliosis With "NEMOST" Growing Rod
A study testing 2 NEMOST rods : bilateral vertebral-pelvic implantation and 1 NEMOST rod :unilateral vertebral-pelvic implantation in people with Progressive Scoliosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the performance of the device "NEMOST" on maintaining of the correction of the scoliosis with growth preservation and avoiding iterative surgeries. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Progressive Scoliosis
- What is being tested?
- 2 NEMOST rods : bilateral vertebral-pelvic implantation and 1 NEMOST rod :unilateral vertebral-pelvic implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2016to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient from 5 to 15 years old
- Patient with neuromuscular scoliosis or progressive scoliosis resistant to conservative treatment
- Patient with an indication of first-line surgery without graft
- Patient with low skeletal maturity (Risser test = 0 and triradiate growth cartilages still open)
- Signing of the consent by the holder (s) of parental authority and the investigator
- Affiliated patient to a health service or entitled patient
Who cannot join
- Patient with a history of spinal surgery
- Patient weighing more than 30 kg and with progressive scoliosis other than neuromuscular
- Patient with contra-indication to Nemost device, that is to say:
- Inflammation or acute Infection, local or systemic,
- Allergy or intolerance titanium or polyetheretherketone,
- Pathology or poor bone quality might compromise the attachment of the device,
Show all 11Show fewer
- Nonreducible Scoliosis,
- Skin Substance insufficient to cover the wound,
- Pathological Obesity,
- Fracture and / or spinal tumor,
- Patient whose behavior presents a risk of failure for the device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficiency of Nemost Growing Spine Device Associated With Physiotherapy in the Surgical Treatment of Progressive Scoliosis of the Child
The purpose of this study is to evaluate the performance of the device "NEMOST" on maintaining of the correction of the scoliosis with growth preservation and avoiding iterative surgeries.
Objective of this study is to evaluate the performance of the growing device "NEMOST" associated to physiotherapy at 12 months postoperatively in patients treated for progressive scoliosis and to evaluate its safety.
Read the detailed description
A number of scoliosis in the child remain progressive despite conservative treatment well conducted. Nowadays the most used treatment is early surgical treatment by the spinal instrumentation without graft called "growing rods". The use of growing rods in patients with progressive scoliosis requires several repeated surgeries (every 6 to 12 months) in order to follow the growth of children. These repeated surgeries lead to a significant increased risk of complications, that's why many teams around the world have been seeking solutions which allow to obtain a rod expansion without repeated surgery.
The purpose of our study is the evaluation of the use of medical device that will perform the correction of scoliosis and, at the same time, preserve the growth of the child's spine. In addition, the purpose of clinical investigation is to test the theory that distraction effort may be exercised without surgery thanks to traction manoeuvres and physiotherapy. This could allow to obtain in patients with progressive scoliosis, correction of spinal deformity while avoiding many repeated surgeries. Our reference device is growing rod "NEMOST". When implanted, NEMOST rod is immediately turned on, for correcting and maintaining the correction of spinal deformity. After implantation, depending on development in Cobb angle, one or more elongations can be made by sliding the notched portion of the rod in its tunnel by a distraction effort (traction equipments and physiotherapy).
Therefore, the growth device NEMOST will allow to continue, on request, the correction of spinal deformity by performing a distraction by external manoeuvres on the notched part without the need for surgery.
- Conditions
- Progressive Scoliosis
- Being tested
- 2 NEMOST rods : bilateral vertebral-pelvic implantation, 1 NEMOST rod :unilateral vertebral-pelvic implantation
- Keywords
- NEMOT device, pediatrics, surgery, progressive scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 NEMOST rods : bilateral vertebral-pelvic implantationDevice
Implantation of two NEMOST rods (bilateral vertebral-pelvic implantation)
1 NEMOST rod :unilateral vertebral-pelvic implantationDevice
Implantation of one NEMOST rod (unilateral vertebral-pelvic implantation)
| Study group | Role | What they receive |
|---|---|---|
| Progressive scoliosis | Experimental | Children with progressive scoliosis Receives: Device: 1 NEMOST rod :unilateral vertebral-pelvic implantation |
| Neuromuscular scoliosis | Experimental | Children with neuromuscular scoliosis Receives: Device: 2 NEMOST rods : bilateral vertebral-pelvic implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
No surgical reoperation
The lack of indication of surgical reoperations means that the correction of scoliosis is satisfactory and the growth had been maintained
Measured: 12 months
No worsening of Cobb angle by more than 15 degrees since the initial correction
A worsening of the Cobb angle by more than 15 ° since the initial correction is considered an indication of reoperation
Measured: 12 months
Secondary outcomes (23)
Cobb angle
Radiographic measure : less than 15 degrees since the initial correction
Measured: 3 months
Cobb angle
Radiographic measure : less than 15 degrees since the initial correction
Measured: 6 months
Cobb angle (degree)
Radiographic measure : less than 15 degrees since the initial correction
Measured: 18 months
reserve rod (mm)
This amount reflects the actual elongation of the device
Measured: 3 months
reserve rod (mm)
This amount reflects the actual elongation of the device
Measured: 6 months
reserve rod (mm)
This amount reflects the actual elongation of the device
Measured: 12 months
reserve rod (mm)
This amount reflects the actual elongation of the device
Measured: 18 months
T1-T12 segment and T1-S1 segment
which reflect the real growth of the spine
Measured: 3 months
T1-T12 segment and T1-S1 segment
which reflect the real growth of the spine
Measured: 6 months
T1-T12 segment and T1-S1 segment
which reflect the real growth of the spine
Measured: 12 months
T1-T12 segment and T1-S1 segment
which reflect the real growth of the spine
Measured: 18 months
respiratory function
Translated chest and lung growth, as well as the actual improvement of respiratory function
Measured: 6 months
respiratory function
Translated chest and lung growth, as well as the actual improvement of respiratory function
Measured: 12 months
respiratory function
Translated chest and lung growth, as well as the actual improvement of respiratory function
Measured: 18 months
Pelvic obliquity (mm)
translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis
Measured: 3 months
Pelvic obliquity (mm)
translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis
Measured: 6 months
Pelvic obliquity (mm)
translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis
Measured: 12 months
Pelvic obliquity (mm)
translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis
Measured: 18 months
Safety of NEMOST
Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST
Measured: 3 months
Safety of NEMOST
Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST
Measured: 6 months
Safety of NEMOST
Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST
Measured: 12 months
Safety of NEMOST
Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST
Measured: 18 months
Weight (kg)
Reflecting the improvement in the general and trophic status of the patient
Measured: Every month for 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start11 Apr 2016
- Primary completion21 Jun 2018
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Progressive ScoliosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Company EUROS, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Nejib KHOURI, MD, PhD, Study director, Hospital Necker Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266667
- Sponsor's protocol ID
- P140301
- Acronym
- NEMOST
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2014
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Miladi L, Khouri N, Pradon J, Elie C, Treluyer JM. One-way self-expanding rod for early-onset scoliosis: early results of a clinical trial of 20 patients. Eur Spine J. 2021 Mar;30(3):749-758. doi: 10.1007/s00586-021-06732-4. Epub 2021 Jan 24.
PubMed 33486593
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Nemost Growing Spine Device Associated With Physiotherapy in the Surgical Treatment of Progressive Scoliosis of the Child
- ClinicalTrials.gov ID
- NCT02266667
- Acronym / sponsor ID
- NEMOST / P140301
- Conditions
- Progressive Scoliosis
- Keywords
- NEMOT device, pediatrics, surgery, progressive scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Company EUROS, URC-CIC Paris Descartes Necker Cochin
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance of the device "NEMOST" on maintaining of the correction of the scoliosis with growth preservation and avoiding iterative surgeries.
Objective of this study is to evaluate the performance of the growing device "NEMOST" associated to physiotherapy at 12 months postoperatively in patients treated for progressive scoliosis and to evaluate its safety.
Detailed description
A number of scoliosis in the child remain progressive despite conservative treatment well conducted. Nowadays the most used treatment is early surgical treatment by the spinal instrumentation without graft called "growing rods". The use of growing rods in patients with progressive scoliosis requires several repeated surgeries (every 6 to 12 months) in order to follow the growth of children. These repeated surgeries lead to a significant increased risk of complications, that's why many teams around the world have been seeking solutions which allow to obtain a rod expansion without repeated surgery.
The purpose of our study is the evaluation of the use of medical device that will perform the correction of scoliosis and, at the same time, preserve the growth of the child's spine. In addition, the purpose of clinical investigation is to test the theory that distraction effort may be exercised without surgery thanks to traction manoeuvres and physiotherapy. This could allow to obtain in patients with progressive scoliosis, correction of spinal deformity while avoiding many repeated surgeries. Our reference device is growing rod "NEMOST". When implanted, NEMOST rod is immediately turned on, for correcting and maintaining the correction of spinal deformity. After implantation, depending on development in Cobb angle, one or more elongations can be made by sliding the notched portion of the rod in its tunnel by a distraction effort (traction equipments and physiotherapy).
Therefore, the growth device NEMOST will allow to continue, on request, the correction of spinal deformity by performing a distraction by external manoeuvres on the notched part without the need for surgery.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive scoliosis | Experimental | Device: 1 NEMOST rod :unilateral vertebral-pelvic implantationChildren with progressive scoliosis |
| Neuromuscular scoliosis | Experimental | Device: 2 NEMOST rods : bilateral vertebral-pelvic implantationChildren with neuromuscular scoliosis |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patient from 5 to 15 years old
- Patient with neuromuscular scoliosis or progressive scoliosis resistant to conservative treatment
- Patient with an indication of first-line surgery without graft
- Patient with low skeletal maturity (Risser test = 0 and triradiate growth cartilages still open)
- Signing of the consent by the holder (s) of parental authority and the investigator
Key exclusion criteria (11 listed)
- Patient with a history of spinal surgery
- Patient weighing more than 30 kg and with progressive scoliosis other than neuromuscular
- Patient with contra-indication to Nemost device, that is to say:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 NEMOST rods : bilateral vertebral-pelvic implantationImplantation of two NEMOST rods (bilateral vertebral-pelvic implantation) | Device | Neuromuscular scoliosis |
| 1 NEMOST rod :unilateral vertebral-pelvic implantationImplantation of one NEMOST rod (unilateral vertebral-pelvic implantation) | Device | Progressive scoliosis |
Primary outcome
No surgical reoperation
Time frame: 12 months
The lack of indication of surgical reoperations means that the correction of scoliosis is satisfactory and the growth had been maintained
No worsening of Cobb angle by more than 15 degrees since the initial correction
Time frame: 12 months
A worsening of the Cobb angle by more than 15 ° since the initial correction is considered an indication of reoperation
23 secondary outcomes
Cobb angle
Time frame: 3 months
Cobb angle
Time frame: 6 months
Cobb angle (degree)
Time frame: 18 months
reserve rod (mm)
Time frame: 3 months
reserve rod (mm)
Time frame: 6 months
reserve rod (mm)
Time frame: 12 months
reserve rod (mm)
Time frame: 18 months
T1-T12 segment and T1-S1 segment
Time frame: 3 months
T1-T12 segment and T1-S1 segment
Time frame: 6 months
T1-T12 segment and T1-S1 segment
Time frame: 12 months
T1-T12 segment and T1-S1 segment
Time frame: 18 months
respiratory function
Time frame: 6 months
respiratory function
Time frame: 12 months
respiratory function
Time frame: 18 months
Pelvic obliquity (mm)
Time frame: 3 months
Pelvic obliquity (mm)
Time frame: 6 months
Pelvic obliquity (mm)
Time frame: 12 months
Pelvic obliquity (mm)
Time frame: 18 months
Safety of NEMOST
Time frame: 3 months
Safety of NEMOST
Time frame: 6 months
Safety of NEMOST
Time frame: 12 months
Safety of NEMOST
Time frame: 18 months
Weight (kg)
Time frame: Every month for 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 33486593Miladi L, Khouri N, Pradon J, Elie C, Treluyer JM. One-way self-expanding rod for early-onset scoliosis: early results of a clinical trial of 20 patients. Eur Spine J. 2021 Mar;30(3):749-758. doi: 10.1007/s00586-021-06732-4. Epub 2021 Jan 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nejib KHOURI, MD, PhD study director
Hospital Necker Enfants Malades
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 NEMOST rods : bilateral vertebral-pelvic implantation and 1 NEMOST rod :unilateral vertebral-pelvic implantation in people with Progressive Scoliosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No surgical reoperation (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02266667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.